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. 2013 Apr 30;2013(4):CD004416. doi: 10.1002/14651858.CD004416.pub2

Bamford 1985.

Study characteristics
Methods Design: randomised, double‐blind, placebo‐controlled, cross‐over
Duration: 6 months (3 months then 3 months reversed)
Interval of assessment: 3 months
Participants Number randomised: 154
Sex (M/F): not stated
Age of participants: completers were 49 children aged 2 to 16 years (mean age = 9.1) and 74 adults aged 16 to 66 years (mean age = 37.7)
Unit of allocation: single participant
Country and setting: USA, single dermatology outpatient department
Inclusion criteria of the study
  • Participants having atopic dermatitis

  • Having used topical steroids

  • Diagnostic criteria: clinical

  • Severity of condition: mild to moderate


Exclusion criteria of the study
  • Participants using systemic steroids or antimetabolites

Interventions
  • Treatment group divided as follows:

    • children < 15 years of age, who received 2 or 4 capsules twice daily each with 500 mg of EPO for 3 months, then crossed over;

    • children > 15 years of age, who received 6 or 8 capsules twice daily each with 500 mg of EPO

  • Placebo group divide in the same way as above and same dosage schedule with each capsule having 500 mg of paraffin oil

Outcomes
  1. Symptoms and signs of eczema (erythema, scaling, excoriation, weeping, etc) by physician (method = 0 to 10 scale, where 0 is none and 10 is most severe)

  2. Symptoms and signs of eczema (erythema, scaling, excoriation, weeping, etc) and effect on daily living (level of discomfort, inability to sleep, etc) by participant (method = 0 to 10 scale, where 0 is none and 10 is most severe)


Interval of assessment: unclear
Notes Concomittent treatment: permitted emollients, topical steroids, and antihistaminics
Compliance to treatment: undertaken
Previous treatment: continued
The trial report did not state the numbers randomised to each group (further information obtained from trial investigator)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The trial used block randomisation
Allocation concealment (selection bias) Low risk Specific study numbers were used on labels, which did not contain medication/placebo name. (The trial investigator provided this further information)
Incomplete outcome data (attrition bias)
All outcomes Low risk 14/77 participants in the EPO group dropped out; 17/77 participants in the placebo group dropped out. They gave reasons
Selective reporting (reporting bias) Low risk The trial reported all prespecified outcomes
Other bias Unclear risk We were unsure whether all participants were included in the analysis in the groups to which they were randomised. We contacted the biostatistician author. A non‐profit foundation funded the trial
Blinding of participants and personnel (performance bias)
All outcomes Low risk This was adequate as both the participant and assessor were blinded. The placebo capsules were identical